FDA.reportPublic FDA data

Nystatin

Product NDC
72162-2007
11-digit product format
721622007
Labeler code
72162
Product ID
72162-2007_8d48c259-ba34-4c5b-b3fe-f1108b33eab3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA207767
Marketing category
ANDA
Marketing start
2020-06-24
Substance
NYSTATIN
Active strength
100000 U/g
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207767-001NYSTATINNYSTATIN100,000 UNITS/GMOINTMENT / TOPICALAT2018-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A207767-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207767-001NYSTATIN100,000 UNITS/GMOINTMENT / TOPICALAT2018-05-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207767-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINZydus Lifesciences Limited6aa2f67e-9636-45e5-be1b-83e7ab86e4362024-08-16Exact identifier
application applno (ANDA): 207767
application number: ANDA207767
NystatinNYSTATINBryant Ranch Prepack93d59122-86f3-489d-9790-1ef6c6aff89d2024-03-26Adverse reactionsExact identifier
application applno (ANDA): 207767
application number: ANDA207767
ndc (product): 72162-2007
NystatinNYSTATINA-S Medication Solutions6a3bb3da-adf9-46d2-a5ff-f796e7aae7a12023-11-24Adverse reactionsExact identifier
application applno (ANDA): 207767
application number: ANDA207767
NystatinNYSTATINBryant Ranch Prepack53d1c23b-9cf2-4941-8701-8a7da1b066cc2023-03-03Adverse reactionsExact identifier
application applno (ANDA): 207767
application number: ANDA207767
NystatinNYSTATINBryant Ranch Prepack84383bc5-1282-43d6-9303-23c8fd8d075f2023-03-03Adverse reactionsExact identifier
application applno (ANDA): 207767
application number: ANDA207767
NystatinNYSTATINViona Pharmaceuticals Ince135a7d2-adba-48a2-b3e1-07b778cce9b02022-10-08Adverse reactionsExact identifier
application applno (ANDA): 207767
application number: ANDA207767

Additional Listing Data#

Finished product
Yes
Brand name base
Nystatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 U/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BDF1O1C72EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884308Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
93d59122-86f3-489d-9790-1ef6c6aff89dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2007-2Nystatin15 g in 1 TUBEOINTMENT15101
72162-2007-3Nystatin30 g in 1 TUBEOINTMENT30101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2007-2GM - Gram72162-2007fd15e3a6-ec41-4797-8049-a66ca040208412024-08-12
72162-2007-3GM - Gram72162-20078276f71f-a84e-428a-b943-207fee34db3312024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2007NYSTATIN OINTMENT [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240328_93d59122-86f3-489d-9790-1ef6c6aff89d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSN93d59122-86f3-489d-9790-1ef6c6aff89d101
884308nystatin 100 UNT/MG Topical OintmentSCD93d59122-86f3-489d-9790-1ef6c6aff89d101
884308nystatin 100,000 UNT/GM Topical OintmentSY93d59122-86f3-489d-9790-1ef6c6aff89d101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2007-27216220070215 g in 1 TUBE (72162-2007-2) 15 g2024-02-06NoNoCurrent
72162-2007-37216220070330 g in 1 TUBE (72162-2007-3) 30 g2024-02-06NoNoCurrent